Evaluation of Clinical Equivalence Between Two Lubiprostone Products
NCT ID: NCT01372423
Last Updated: 2012-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
808 participants
INTERVENTIONAL
2011-05-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AMITIZA
Manufactured by Sucampo Pharmaceuticals (24 mcg administered for 7 days)
Lubiprostone
24 mcg capsules
Placebo
Manufactured by Anchen Pharmaceuticals (24 mcg administered for 7 days)
Placebo
24 mcg capsules
Lubiprostone
Manufactured by Anchen Pharmaceuticals (24 mcg administered for 7 days)
Lubiprostone
24 mcg capsules
Interventions
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Lubiprostone
24 mcg capsules
Placebo
24 mcg capsules
Eligibility Criteria
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Inclusion Criteria
2. Have 1 or more of the following symptoms related to bowel movements for at least 6 months before the baseline visit and confirmed by daily diary during the 14 Day baseline period:
* very hard (little balls) and/or hard stools for at least 25 percent of the bowel movements
* sensation of incomplete evacuation following at least 25 percent of the bowel movements
* straining at defecation at least a quarter of the time
3. Women of child-bearing potential must have a negative pregnancy test prior to beginning therapy and agree to use effective contraceptive methods during the study.
4. For patients aged \< 50 years, documentation of the results of either a flexible sigmoidoscopy or colonoscopy performed within the 5 years prior to dosing, showing no mechanical bowel obstruction or organic disorders of the large Bowel.
5. For patients aged \>/= 50 years, documentation of the results of either a barium enema with flexible sigmoidoscopy or colonoscopy performed within 1 year prior to dosing, showing no mechanical bowel obstruction or organic disorders of the large bowel.
Exclusion Criteria
2. Patients of any age with evidence of weight loss, anemia, or rectal bleeding AND without documentation of the results of either a flexible sigmoidoscopy or colonoscopy performed during the 6 months prior to dosing.
3. Patients that have documented mechanical bowel obstruction (e.g., bowel obstruction due to tumor, hernia), megacolon/megarectum, or diagnosis of pseudo-obstruction.
4. Any known or suspected organic disorders of the large or small bowel (e.g., inflammatory bowel disease, ulcerative colitis, Crohn's Disease) or constipation secondary to a documented cause (e.g., surgery, bowel resection)or acute hernia.
5. History of bowel resection.
6. Patients who are regularly using medications know to cause constipation (narcotics, calcium channel blockers, tricyclic antidepressants).
7. Hospitalized for any gastrointestinal or abdominal surgical procedure during the 3 months prior to dosing.
8. Clinically significant cardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or clinically significant laboratory abnormalities.
9. Use of a systemic antibiotic within 4 weeks prior to the Screening Visit.
10. Participation in a study with any investigational medication within the past 30 days of screening for this study or previous participation in this study.
18 Years
ALL
No
Sponsors
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Novum Pharmaceutical Research Services
INDUSTRY
Anchen Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Locations
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Novum Investigator Site
Dothan, Alabama, United States
Novum Investigator Site
Huntsville, Alabama, United States
Novum Investigator Site
Mobile, Alabama, United States
Novum Investigator Site
Chandler, Arizona, United States
Novum Investigator Site
Gilbert, Arizona, United States
Novum Investigator Site
Mesa, Arizona, United States
Novum Investigator Site
Phoenix, Arizona, United States
Novum Investigator Site
Phoeniz, Arizona, United States
Novum Investigator Site
Hot Springs, Arkansas, United States
Novum Investigator Site
Little Rock, Arkansas, United States
Novum Investigator Site
Mountain Home, Arkansas, United States
Novum Investigator Site
Sherwood, Arkansas, United States
Novum Investigator Site
Buena Park, California, United States
Novum Investigator Site
Fresno, California, United States
Novum Investigator Site
Garden Grove, California, United States
Novum Investigator Site
La Palma, California, United States
Novum Investigator Site
Long Beach, California, United States
Novum Investigator Site
Sacremento, California, United States
Novum Investigator Site
San Diego, California, United States
Novum Invesitgator Site
San Ramon, California, United States
Novum Investigator Site
Santa Ana, California, United States
Novum Investigator Site
Westlake Village, California, United States
Novum Investigator Site
Denver, Colorado, United States
Novum Investigator Site
Wheat Ridge, Colorado, United States
Novum Investigator Site
Adventura, Florida, United States
Novum Investigator Site
Boyton Beach, Florida, United States
Novum Investigator Site
Bradenton, Florida, United States
Novum Investigator Site
Brookville, Florida, United States
Novum Investigator Site
Clearwater, Florida, United States
Novum Investigator Site
Deerfield Beach, Florida, United States
Novum Investigator Site
Jupiter, Florida, United States
Novum Investigator Site
Maimi, Florida, United States
Novum Investigator Site
Miami, Florida, United States
Novum Investigator Site
Niceville, Florida, United States
Novum Investigator Site
Ormond Beach, Florida, United States
Novum Investigator Site
Panama City, Florida, United States
Novum Investigator Site
Port Orange, Florida, United States
Novum Investigator Site
St. Petersburg, Florida, United States
Novum Investigator Site
Tampa, Florida, United States
Novum Investigator Site
West Palm Beach, Florida, United States
Novum Investigator Site
Decauter, Georgia, United States
Novum Investigator Site
Sandy Springs, Georgia, United States
Novum Investigator Site
Stockbridge, Georgia, United States
Novum Investigator Site
Lewiston, Idaho, United States
Novum Investigator Site
Rockford, Illinois, United States
Novum Investigator Site
Evansville, Indiana, United States
Novum Investigator Site
Lexington, Kentucky, United States
Novum Investigator Site
Shreveport, Louisiana, United States
Novum Invesitgator Site
Hollywood, Maryland, United States
Novum Investigator Site
Jackson, Mississippi, United States
Novum Investigator Site
Mexico, Missouri, United States
Novum Investigator Site
Washington, Missouri, United States
Novum Investigator Site
Billings, Montana, United States
Novum Investigator Site
Lincoln, Nebraska, United States
Novum Investigator Site
Henderson, Nevada, United States
Novum Investigator Site
Marlton, New Jersey, United States
Novum Investigator Site
Newport News, New Jersey, United States
Novum Investigator Site
Poughkeepsie, New York, United States
Novum Investigator Site
Cary, North Carolina, United States
Novum Investigator Site
Charlotte, North Carolina, United States
Novum Investigator Site
High Point, North Carolina, United States
Novum Investigator Site
Raleigh, North Carolina, United States
Novum Investigator Site
Salisbury, North Carolina, United States
Novum Investigator Site
Wilmington, North Carolina, United States
Novum Investigator Site
Winstom-Salem, North Carolina, United States
Novum Investigator Site
Beavercreek, Ohio, United States
Novum Investigator Site
Centerville, Ohio, United States
Novum Investigator Site
Sylvania, Ohio, United States
Novum Investigator Site
Columbia, South Carolina, United States
Novum Investigator Site
Chattanooga, Tennessee, United States
Novum Investigator Site
Germantown, Tennessee, United States
Novum Investigator Site
Hermitage, Tennessee, United States
Novum Investigator Site
Houston, Texas, United States
Novum Investigator Site
Longview, Texas, United States
Novum Investigator Site
San Antonio, Texas, United States
Novum Investigator Site
Sugarland, Texas, United States
Novum Investigator Site
Charlottesville, Virginia, United States
Novum Investigator Site
Virginia Beach, Virginia, United States
Novum Investigator Site
Mountain Lake, Washington, United States
Countries
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Other Identifiers
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71060001
Identifier Type: OTHER
Identifier Source: secondary_id
CS-01-2011
Identifier Type: -
Identifier Source: org_study_id